1117-0013 Supporting Statement

Supporting Statement for Paperwork Reduction Act Submissions

DEA Form 357

Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes pursuant to 21 U.S.C. 952

[OMB 1117-0013]

Part A. Justification

1. Necessity of Information: Title 21, Code of Federal Regulations (CFR) 1312.11, requires any registrant who desires to import certain controlled substances into the United States to have an import permit. In order to obtain the permit, an application must be made to the Drug Enforcement Administration (DEA) on DEA Form 357.

2. Needs and Uses: DEA uses this information to determine a registrant’s suitability for issuance of an Import Permit and not to exceed import quota assignments.

3. Use of Technology: Currently DEA Form 357 is available as a partially interactive form on the Diversion Control Program web site. Persons complete the form on screen, print it and mail it to DEA.

4. Efforts to Identify Duplication: Importation of controlled substances into the United States is unique to DEA, therefore there is no duplication of information.

5. Methods to Minimize Burden on Small Businesses: This collection has no significant impact upon small entities within the meaning and intent of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq.

6. Consequences of Less Frequent Collection: If the collection is not conducted or conducted less frequently, DEA would not have sufficient information to enforce the statute and comply with requirements under international agreements.

7. Special Circumstances Influencing Collection: The law requires respondents to submit reports on an occasional basis. None of the circumstances in Item 7 applies to this collection.

8. Reasons for Inconsistencies with 5 CFR 1320.6: DEA establishes and participates in training seminars, industry meetings and conferences, etc., with the regulated import and export industry. These meetings provide an open forum to discuss matters of mutual concern, including import application procedures with industry representatives.

DEA published the 60-day notice, 72 FR 18668, and the 30-day notice, 72 FR 34278, in the Federal Register and did not receive any comments concerning this collection.

9. Payment or Gift to Claimants: There are no payments or gifts to respondents.

10. Assurance of Confidentiality: Confidential business information is protected under Department of Justice regulations, 28 CFR 16.8 and 16.9.

11. Justification for Sensitive Questions: DEA reports do not include questions of a sensitive nature.

12. Estimate of Hour Burden:

Respondents report on DEA Form 357. A respondent may submit multiple responses.

Number of Respondents: 47

Frequency of Response: On occasion

Average annual responses: 406

Average time per response: .25 hour (15 minutes)

Total annual burden: 101.5 hours

Cost to respondents:

Number of Responses x Time per Response x $10 per hour = Total Industry Costs

406 x .25 hour x $10 = $1015

13. Estimate of Cost Burden:

Mailing:

406 x .39 = $158.34

14. Estimated Annualized Cost to Federal Government:

Cost to Federal Government:

Review and Analysis:

1 Unit Chief GS-14 (2% of time): $2,295

Review and Processing:

1 Import-Export Specialist GS-12 (6% of time): $4,901

1 Import-Export Specialist GS-11 (3% of time): $2,044

Clerical Support:

1 Secretary GS-6 (1% of time): $414

Total personnel costs: $9,654

Miscellaneous Costs:

Printing $2,500

Mailing $140

Total Cost to Government: $12,294

15. Reasons for Change in Burden: The adjustments to Items 12 and 14 are due to a slight increase in the number of exports by fewer registrants. There has been no program change.

16. Plans for Publication: There are no plans to publish this information.

17. Expiration Date Approval: DEA is not seeking approval too not display the expiration date for OMB approval of the information collected.

18. Exceptions to the Certification Statement: There are no exceptions to the certification requirement.

Part B. Statistical Methods

The Drug Enforcement Administration will not be employing statistical methods in this information collection.